Devices And Methods For Positioning And Monitoring Tether Load For Prosthetic Mitral Valve

ABSTRACT

Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/251,269, filed on Aug. 30, 2016, which is a continuation ofInternational Application No. PCT/US2015/019418, filed Mar. 9, 2015,which claims priority to and the benefit of U.S. Provisional PatentApplication No. 61/950,429, filed Mar. 10, 2014, entitled “Devices andMethods for Monitoring Tether Load for Prosthetic Mitral Valve,” U.S.Provisional Patent Application No. 61/970,887, filed Mar. 26, 2014,entitled “Post-Deployment Adjustment of a Prosthetic Mitral Valve,” andU.S. Provisional Patent Application No. 61/970,882, filed Mar. 26, 2014,entitled “Post-Deployment Adjustment of a Prosthetic Mitral Valve.” Thedisclosure of each of the foregoing applications is incorporated hereinby reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to devices and methods foranchoring a medical device such as a prosthetic heart valve replacement,and more particularly to devices and methods for the post-deploymentadjustment and/or re-positioning of such a medical device.

Some known prosthetic heart valves, such as prosthetic mitral valves,include one or more tethers that extend from the valve to the exteriorof the heart, and are secured to an outer ventricular wall of the heartwith an epicardial anchor device. During such procedures, positioningthe anchor device and providing a desired tension to the securing tethercan be challenging. Many known devices do not have the ability to makeadjustments to the anchor device or to the tension of the tether afterinitial placement. Further, known devices do not have the ability tomeasure and monitor the tension on the tether during deployment of thevalve to assist in providing an optimal tension and position.

Some problems associated with improper tensioning of a securing tethercan include, for example, the tether becoming progressively slack overtime, a tether which has been overtightened and is deforming thepositioning of the deployed valve, and a tether which has been deployedin a less than optimal angular configuration or has migrated such thatthe valve axis is no longer orthogonal to the plane of the nativevalve's annulus.

Accordingly, there is a need for devices and methods for adjustingand/or repositioning a prosthetic heart valve after its initialdeployment and for monitoring the tension on a securing tether extendingfrom the prosthetic heart valve.

SUMMARY

Apparatus and methods are described herein for positioning an epicardialanchor device and measuring the load of a tether extending from aprosthetic heart valve and coupled to the epicardial anchor device. Insome embodiments, an apparatus includes a handle assembly coupled to anelongate member and a docking member coupled to a distal end of theelongate member. The docking member can be releasably coupled to anepicardial anchor device configured to secure a tether extending from aprosthetic heart valve implanted with a heart at a location on anexterior of a ventricular wall of the heart. A force sensor device iscoupled to the handle assembly and can measure a force exerted on theforce sensor device. The force is associated with a tension of thetether extending through the elongate member, handle assembly and forcesensor device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-sectional illustration of portion of a heartwith a prosthetic mitral valve implanted therein and an epicardialanchor device anchoring the mitral valve in position.

FIG. 2 is a schematic illustration of an epicardial anchor device,according to an embodiment.

FIG. 3 is a schematic illustration of a positioning device, according toan embodiment.

FIG. 4 is a top perspective view of an epicardial anchor device,according to another embodiment.

FIG. 5 is a top view of the epicardial anchor device of FIG. 4.

FIG. 6 is an exploded view of the epicardial anchor device of FIG. 4.

FIG. 7 is a cross-sectional perspective view of the epicardial anchordevice of FIG. 4 with a locking pin of the device shown in a firstposition.

FIG. 8 is a cross-sectional side view of the epicardial anchor device ofFIG. 4 with the locking pin of the device shown in the first position.

FIG. 9 is a cross-sectional bottom perspective view of the epicardialanchor device of FIG. 4 with the locking pin shown in a second position.

FIGS. 10 and 11 are a top perspective and a bottom perspective view,respectively, of a hub member of the epicardial anchor device of FIG. 4.

FIG. 12 is an enlarged top view of a portion of the epicardial anchordevice of FIG. 4.

FIG. 13 is a perspective view of a positioning device, according to anembodiment.

FIG. 14 is a top view of a portion of the positioning device of FIG. 13.

FIG. 15 is a cross-sectional view of the portion of the positioningdevice of FIG. 14.

FIG. 16A is a perspective view and FIG. 16B is a top view of a portionof the positioning device of FIG. 13.

FIG. 17A is a perspective view of a portion of the positioning device ofFIG. 13 shown partially exploded.

FIG. 17B is a perspective view of the portion of the positioning deviceof FIG. 17A.

FIG. 18 is a top view of a positioning device, according to anotherembodiment.

FIG. 19 is a perspective view of a portion of the positioning device ofFIG. 18 shown partially exploded.

FIG. 20 is a perspective view of the portion of the positioning deviceof FIG. 19.

FIG. 21 is a schematic illustration of a portion of the positioningdevice of FIG. 18.

FIG. 22 is a perspective view of a positioning device, according toanother embodiment, shown coupled to an epicardial anchor device.

FIG. 23 is a top view of the positioning device of FIG. 22.

FIG. 24 is a cross-sectional view of a portion of the positioning deviceof FIG. 22, taken along line 24-24 in FIG. 23.

FIG. 25 is a perspective view of a portion of the positioning device ofFIG. 22.

FIG. 26 is a perspective view of a force sensor device of thepositioning device of FIG. 22.

FIG. 27 is an exploded perspective view of the force sensor device ofFIG. 26.

FIG. 28 is a perspective view of a portion of the force sensor device ofFIG. 26.

FIG. 29 is a perspective view of a portion of the positioning device ofFIG. 22.

FIG. 30 is a side view of the positioning device of FIG. 22.

FIG. 31 is a partial cross-sectional side view of a tension limitingdevice according to an embodiment.

FIG. 32 is a top view of a tether release tool, according to anembodiment.

FIG. 33 is a perspective view of an end portion of the tether releasetool of FIG. 32.

FIG. 34 is a perspective view of a portion of the tether release tool ofFIG. 32 shown being coupled to an epicardial anchor device.

FIG. 35 is a perspective view of a portion of the tether release tool ofFIG. 32 shown coupled to the epicardial anchor device of FIG. 34.

FIG. 36 is a perspective view of a force sensor device according to anembodiment.

FIG. 37 is an exploded perspective view of the force sensor device ofFIG. 36.

FIG. 38 is a cross-sectional perspective view of the force sensor deviceof FIG. 36.

FIG. 39 is a side view of a portion of a tether with a marker bandaccording to an embodiment.

DETAILED DESCRIPTION

Apparatus and methods are described herein that can be used for thepost-deployment adjustment and/or re-positioning of a transcatheterprosthetic heart valve, such as a mitral valve, that has been deployedinto the annulus of a native valve, such as a mitral valve. For example,such a prosthetic mitral valve can be anatomically secured in atwo-phase process that includes securing the prosthetic mitral valve inthe native annulus using an atrial cuff and a tether axial tensioningsystem in combination with a laterally expanded stent, and to methodsfor making such systems.

In some embodiments, apparatus and methods are described herein formonitoring the tension applied to a securing tether extending from aprosthetic mitral valve that has been deployed into the native mitralvalve.

Various embodiments described herein address problems concerning valvedelivery and deployment, valve compliance, perivalvular leaking,hemodynamic issues such as left ventricular outflow tract (LVOT)interference, clotting, cardiac remodeling, etc.

In some embodiments, an adjustable tether and epicardial anchor devicefor a compressible prosthetic heart valve replacement are describedherein, which can be deployed into a closed beating heart using, forexample, a transcatheter delivery system. In some embodiments, such avalve replacement device can be deployed in a minimally invasive fashionand by way of example considers a minimally invasive surgical procedureutilizing the intercostal or sub-xyphoid space for valve introduction.To accomplish this, the valve is formed so that it can be compressed tofit within a delivery system and then ejected from the delivery systeminto the target location, for example, the annulus of the mitral ortricuspid valve.

In some embodiments, there is provided a method of adjusting the lengthand/or tension of a tether for a tethered transcatheter prosthetic heartvalve after a transcatheter valve implantation procedure in a patient.Such a method can include adjusting the transluminal length of aventricular tether, wherein the tether is anchored between an epicardialanchor device that is releasably affixed to an external epicardialsurface of the heart and a valve-based fastening system on atranscatheter prosthetic heart valve that is deployed in the nativevalve annulus of the patient. Upon releasing the tether from theepicardial anchor device, the tether length and/or tension is adjustedand the tether is re-fastened to the epicardial anchor device.

In another embodiment, there is provided a method as above, furtherincluding capturing the tether, threading the tether through a tetherrelease tool, re-engaging the tether release tool with the epicardialanchor device, unlocking the pin and releasing the tether. In someembodiments, after adjusting the length of the tether (longer orshorter), the tether tensioning force can be measure again, and then thetether can be re-pinned into the epicardial anchor device.

In some embodiments, there is provided a device for adjusting the lengthand/or tension of a tether for a tethered transcatheter prosthetic heartvalve after a transcatheter valve implantation procedure in a patient.The device can include a positioning device for operatively engaging anepicardial anchor device, and the positioning device includes apositioning rod. The positioning rod member includes at a distal end ofan elongate member a docking member that has a hinged frame that isconnected to a circular platform having two bent locking tines orflanges located across from each other. The elongate member may or maynot be hollow and includes a mechanism associated therewith forinserting or withdrawing a locking pin from a tether. The positioningdevice further includes a pin locking thumb wheel sub-component toactuate the pin locking mechanism that drives or removes a piercing pinon the epicardial anchor device into or from the tether. The positioningdevice further includes a transparent segment between the pin lockingthumb wheel and a proximal end of the positioning device. Thetransparent segment has an implant position scale marked thereon. Aproximal end of the positioning device also has a tether attachment pinvise. When the tether is threaded through the epicardial anchor deviceand the positioning device, and when the tether is drawn/pulled to thedesired tension, e.g., such that the deployed valve seats firmly in thenative annulus and any regurgitation seen on fluoroscopy orechocardiography is no longer present, the tether tensioning can beadjusted by visually observing the tether within the transparent segmentof the positioning device and comparing the longitudinal distancetravelled against an implant position scale. After the tether issuitably located, the pin locking thumb wheel is actuated and the pinlocks the tether in place on the epicardial anchor device. The dockingmember is then disengaged from the epicardial anchor device.

In some embodiments, there is provided a tether release tool that has adistal tip that includes a shaped anchor device-engagement tip, a distalopening and a passageway in fluid communication with an angled tethercapture/recapture access port. The angled tether capture/recaptureaccess port allows a tether to be captured and released from a lockedposition, and the shaped anchor device-engagement tip is configured tofit within a similarly shaped portion of an epicardial anchor device.

In some embodiments, there is provided a method of tethering aprosthetic heart valve during a transcatheter valve replacementprocedure that includes deploying a transcatheter prosthetic heart valvein a patient using as an anchor an adjustable tether that is anchoredwithin the heart between an apically affixed epicardial anchor deviceand a stent-based fastening system (e.g., attached to the prostheticheart valve). The transcatheter prosthetic heart valve includes anexpandable tubular stent having a cuff and an expandable internalleaflet assembly. The cuff includes wire covered with stabilized tissueor synthetic material, and the leaflet assembly is disposed within thestent and includes stabilized tissue or synthetic material.

In some embodiments, an epicardial anchor device for anchoring atransluminal (transventricular) suture/tether includes a substantiallyrigid suturing disk having a tether-capture mechanism such as an axialtunnel, a winding channel, or a functional equivalent, and a tetherlocking mechanism such as a locking pin or screw that intersects theaxial tunnel, a locking pin or screw operatively associated with thewinding channel, a cam device like a rope lock that grips the tether bycompression between two cams or a cam and fixed locking wall, a metalcompression fastener, a tooth and pawl device, various combinations ofthe above, or a functional equivalent thereof.

In another embodiment, an epicardial anchor device for anchoring atransluminal suture includes a substantially rigid suturing disk havingan axial tunnel, a locking pin locking pin tunnel that intersects theaxial tunnel, a locking pin operatively associated with the locking pintunnel, one or more radial channels that do not intersect with the axialtunnel and that do not intersect the locking pin tunnel, and a windingchannel circumferentially disposed within a perimeter sidewall of thedisk.

In some embodiments, an epicardial anchor device further includes apolyester velour coating. In some embodiments, the one or more radialchannels include four radial channels. In some embodiments, the one ormore radial channels each have an enlarged axial keyhole tunnel.

In some embodiments, an epicardial anchor device includes a flexible padoperatively associated with the rigid tethering/suturing disk, and theflexible pad has a through-hole longitudinally aligned with the axialtunnel. In some embodiments, the epicardial anchor device furtherincludes a sleeve gasket operatively associated with the rigidtethering/suturing disk, and the sleeve gasket has a lumenlongitudinally aligned with the axial tunnel. In some embodiments, thedevice further includes a sleeve gasket attached to the rigidtethering/suturing disk and a flexible pad attached to the sleevegasket. In such an embodiment, the sleeve gasket has a lumenlongitudinally aligned with the axial tunnel of the tethering/suturingdisk, and the flexible pad has a through-hole longitudinally alignedwith both the lumen of the sleeve gasket and the axial tunnel of thetethering/suturing disk.

In some embodiments, a device for anchoring a transluminaltethering/suture includes a substantially rigid tethering/suturing disk,a sleeve gasket connected to the tethering/suturing disk, and a flexiblepad connected to the sleeve gasket. The substantially rigidtethering/suturing disk has an axial tunnel, a locking pin tunnel thatintersects the axial tunnel, a locking pin operatively associated withthe locking pin tunnel, one or more radial channels that do notintersect with the axial tunnel and that do not intersect the lockingpin tunnel, and a winding channel circumferentially disposed within aperimeter sidewall of the disk. The sleeve gasket is in longitudinalalignment with the axial tunnel, and the flexible pad has a through-holelongitudinally aligned with both the lumen of the sleeve gasket and theaxial tunnel of the tethering/suturing disk.

In another embodiment, an epicardial anchor device for anchoring atransluminal suture includes a substantially rigid tethering/suturingdisk having an axial tunnel, a locking pin tunnel that intersects theaxial tunnel, and a locking pin operatively associated with the lockingpin tunnel.

In some embodiments, a method for anchoring a transluminal sutureincludes affixing a transluminal suture to an epicardial anchor deviceas described herein, and positioning the epicardial anchor deviceexternal to a body lumen. The transluminal tether/suture extends fromwithin the lumen to the epicardial anchor device.

In another embodiment, a tether and epicardial anchor device asdescribed herein further includes a tether tension load measuring deviceoperatively associated with the tether. In some embodiments, a tensionsensor includes one or more electronic strain gage transducers. Thetension sensor can be configured for dynamic tension, static tension, orboth dynamic and static tension measurement. In some embodiments, thetether is loaded with a specific tension, such as, for example, 1.0 to4.0 lbs.

In another embodiment, there is provided a device and exemplary methodfor monitoring and/or controlling tether load during implant positioningusing a fluid chamber device described in more detail below. A forcesensor device having an annular fluid chamber is installed on theproximal end of a positioning device. This chamber is connected to apressure transducer and then connected to a monitoring display. In someembodiments, a mechanical indicator can be used in conjunctiontherewith. A spring device may be connected to a mechanical tensionmeter to show load range. In some embodiments, the force sensor deviceremains as an integral part of the epicardial fastening pad assembly andis not removed after the tether tensioning is performed.

In some embodiments, a sterile surgical kit can be provided. The sterilesurgical kit can contain a transcatheter delivery system, an epicardialanchor device and/or a transcatheter prosthetic valve.

In another embodiment, there is provided method of treating mitral ortricuspid regurgitation in a patient, which includes surgicallydeploying an adjustable-tethered prosthetic heart valve into the mitralor tricuspid annulus of the patient.

In another embodiment, the space between the cuff tissue and cuff Dacronliner (inside-outside) may be used to create a cuff that is expandable,swellable or may be inflated, and which provides an enhanced level ofsealing of the cuff against the annular tissue.

Various embodiments described herein address problems concerning valvedelivery and deployment, valve compliance, perivalvular leaking,hemodynamic issues such as LVOT interference, clotting, cardiacremodeling and so forth.

In some embodiments described herein, a tethering system for aprosthetic mitral valve is provided that is designed to maintainintegrity to about 800 million cycles, or about 20 years. The use of acompressible prosthetic valve delivered via transcatheter endoscopetechniques addresses various delivery issues. Deployment is addressedthrough the use of a prosthetic valve having a shape that features atubular stent body that contains leaflets and an atrial cuff. Thisallows the valve to seat within the mitral annulus and be held by thenative mitral leaflets. The use of a flexible valve attached using anapical tether provides compliance with the motion and geometry of theheart. The geometry and motion of the heart are well-known as exhibitinga complicated biphasic left ventricular deformation with musclethickening and a sequential twisting motion. The additional use of theapically secured ventricular tether helps maintain the prostheticvalve's annular position without allowing the valve to migrate, whileproviding enough tension between the cuff valve annulus to reduce andeliminate perivalvular leakage. The use of an adjustable tether or anadjustable paired-tether that is attached to an apical location canreduce or eliminate the cardiac muscle remodeling that has beenwitnessed in prior art devices. Some prior art devices can have aproblem with unwanted change in tissue at the anchoring locations, aswell as heart-generated migration of the original anchoring locations tonew locations that reduce or destroy the prior art valve'seffectiveness. The use of a compliant valve prosthesis and the specialshape and features help reduce or eliminate clotting and hemodynamicissues, including LVOT interference problems. Many prior art valves werenot designed with an awareness of, or were not able to address, problemswith blood flow and aorta/aortic valve compression issues.

Structurally, a prosthetic heart valve as used with the apparatus andmethods described herein can include a self-expanding tubular bodyhaving a cuff at one end and one or more tethers attached at the otherend. Disposed within the tubular body is a leaflet assembly thatcontains the valve leaflets, and the valve leaflets can be formed fromstabilized tissue or other suitable biological or synthetic material. Inone embodiment, the leaflet assembly may include a wire form where aformed wire structure is used in conjunction with stabilized tissue tocreate a leaflet support structure which can have anywhere from 1, 2, 3or 4 leaflets, or valve cusps disposed therein. In another embodiment,the leaflet assembly is wireless and uses only the stabilized tissue andstent body to provide the leaflet support structure, without using wire,and which can also have anywhere from 1, 2, 3 or 4 leaflets, or valvecusps disposed therein.

The upper cuff portion may be formed by heat-forming a portion of atubular Nitinol® braided (or similar) stent such that the lower portionretains the tubular shape, but the upper portion is opened out of thetubular shape and expanded to create a widened collar structure that maybe shaped in a variety of functional regular or irregular funnel-like orcollar-like shapes. In one embodiment, the entire structure is formedfrom a laser-cut stent and collar design, as described further herein

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

As used herein, the words “proximal” and “distal” refer to a directioncloser to and away from, respectively, an operator of, for example, amedical device. Thus, for example, the end of the medical device closestto the patient's body (e.g., contacting the patient's body or disposedwithin the patient's body) would be the distal end of the medicaldevice, while the end opposite the distal end and closest to, forexample, the user (or hand of the user) of the medical device, would bethe proximal end of the medical device.

A prosthetic mitral valve can be anchored to the heart at a locationexternal to the heart via one or more tethers coupled to an anchordevice, as described herein. For example, the tether(s) can be coupledto the prosthetic mitral valve and extend out of the heart and besecured at an exterior location (e.g., the epicardial surface) with ananchor device, as described herein. An anchor device as described hereincan be used with one or more such tethers in other surgical situationswhere such a tether may be desired to extend from an intraluminal cavityto an external anchoring site. Various different types and/orconfigurations of an anchor device (also referred to herein as“epicardial anchor device” or “epicardial pad” or “pad”) can be used toanchor a prosthetic mitral valve in the methods described herein. Forexample, any of the epicardial anchor devices described in PCTInternational Application No. PCT/US2014/049218, filed Jul. 31, 2014,entitled “Epicardial Anchor Devices and Methods,” (referred to herein as“the '218 PCT application”), the disclosure of which is incorporatedherein by reference in its entirety, can be used.

FIG. 1 is a schematic cross-sectional illustration of the left ventricleLV and left atrium LA of a heart H having a transcatheter prostheticmitral valve PMV deployed therein and an epicardial anchor device EAD asdescribed herein securing the prosthetic mitral valve PMV in place. FIG.1 illustrates the prosthetic mitral valve PMV seated into the nativevalve annulus and held there using an atrial cuff AC of the prostheticmitral valve PMV and a ventricular tether T secured with attachmentportions Tp to the prosthetic mitral valve PMV and to the epicardialanchor EAD. The epicardial anchor device EAD can be various differentshapes, sizes, types and configurations, for example, the EAD can be anepicardial anchor device such as those described in the '218 PCTapplication incorporated by reference above. Further, the prostheticmitral valve PMV and the tether T can be, for example, a prostheticmitral valve and tether, respectively, as described in the '218 PCTapplication or other suitable types and configurations.

FIG. 2 is a schematic illustration of an epicardial anchor device 100(also referred to herein as “anchor device” or “epicardial anchor”)according to an embodiment. The anchor device 100 can be used to anchoror secure a prosthetic mitral valve PMV deployed between the left atriumLA and left ventricle LV of a heart H. The anchor device 100 can beused, for example, to anchor or secure the prosthetic mitral valve PMVvia a suturing tether 128 as described above with respect to FIG. 1. Theanchor device 100 can also seal a puncture formed in the ventricularwall (not shown in FIG. 2) of the heart during implantation of theprosthetic mitral valve PMV. The anchor device 100 can also be used inother applications to anchor a medical device (such as any prostheticatrioventricular valve or other heart valve) and/or to seal an openingsuch as a puncture.

The anchor device 100 can include a pad (or pad assembly) 120, a tetherattachment member 124 and a locking pin or locking pin assembly 126. Thepad 120 can contact the epicardial surface of the heart and can beconstructed of any suitable biocompatible surgical material. The pad 120can be used to assist the sealing of a surgical puncture formed whenimplanting a prosthetic mitral valve.

In some embodiments, the pad 120 can be made with a double velourmaterial to promote ingrowth of the pad 120 into the puncture site area.For example, pad or felt pledgets can be made of a felted polyester andmay be cut to any suitable size or shape, such as those available fromBard® as PTFE Felt Pledgets having a nominal thickness of 2.87 mm. Insome embodiments, the pad 120 can be larger in diameter than the tetherattachment member 124. The pad 120 can have a circular or disk shape, orother suitable shapes.

The tether attachment member 124 can provide the anchoring and mountingplatform to which one or more tethers 128 can be coupled (e.g., tied orpinned). The tether attachment member 124 can include a base member (notshown) that defines at least a portion of a tether passageway (notshown) through which the tether 128 can be received and pass through thetether attachment member 124, and a locking pin channel (not shown)through which the locking pin 126 can be received. The locking pinchannel can be in fluid communication with the tether passageway suchthat when the locking pin 126 is disposed in the locking pin channel,the locking pin 126 can contact or pierce the tether 128 as it passesthrough the tether passageway as described in more detail below withreference to specific embodiments.

The locking pin assembly 126 can be used to hold the tether 128 in placeafter the anchor device 100 has been tightened against the ventricularwall and the tether 128 has been pulled to a desired tension. Forexample, the tether 128 can extend through a hole in the pad 120, andthrough the tether passageway of the tether attachment member 124. Thelocking pin 126 can be inserted or moved within the locking pin channel134 such that it pierces or otherwise engages the tether 128 as thetether 128 extends through the tether passageway of the tetherattachment member 124. Thus, the locking pin 126 can intersect thetether 128 and secure the tether 128 to the tether attachment member124.

The tether attachment member 124 can be formed with, a variety ofsuitable biocompatible material. For example, in some embodiments, thetether attachment member 124 can be made of polyethylene, or other hardor semi-hard polymer, and can be covered with a polyester velour topromote ingrowth. In other embodiments, the tether attachment member 124can be made of metal, such as, for example, Nitinol®, or ceramicmaterials. The tether attachment member 124 can be various sizes and/orshapes. For example, the tether attachment member 124 can besubstantially disk shaped.

In use, after a PMV has been placed within a heart, the tether extendingfrom the PMV can be inserted into the tether passageway of the anchordevice 100 and the tension on the tether attachment device can beadjusted to a desired tension. Alternatively, in some cases, the tetherextending from the PMV can be coupled to the anchor device 100 prior tothe PMV being placed within the heart. The anchor device 100 (e.g., someportion of the anchor device such as the tether attachment member 124,or the lever arm or hub depending on the particular embodiment) can beactuated such that the locking pin 126 intersects the tether passagewayand engages a portion of the tether disposed within the tetherpassageway, securing the tether to the tether attachment member. In someembodiments, prior to inserting the tether into the tether passageway,the anchor device 100 can be actuated to configure the anchor device 100to receive the tether. For example, if the tether attachment memberincludes a lever arm movably coupled to the base member, the lever armmay need to be moved to an open position to allow the tether to beinserted. In some embodiments, the anchor device 100 can be actuated byrotating a hub relative to a base member of the tether attachment member124 such that the locking pin 126 is moved from a first position inwhich the locking pin is spaced from the tether passageway and a secondposition in which the locking pin intersects the tether passageway andengages or pierces the portion of the tether.

FIG. 3 is a schematic illustration of an embodiment of a positioningdevice 142 that can be used to position the epicardial anchor device 100and measure the tension applied to a tether 128 attached to a prostheticmitral valve (not shown in FIG. 3) to be anchored by the epicardialanchor device 100. The positioning device 142 includes a handle assembly144, an elongate member 145, a docking member 146, and a tether securingmember 147. In some embodiments, the positioning device 142 can includea force sensor device 148, which can communicate with a transducer 149,which in turn can communicate with an electronic device 141 to displaythe output of the force sensor device 148. In some embodiments, thetransducer 149 can be incorporated within the force sensor device 148.In some embodiments, the force sensor device 148 can be coupled to adata acquisition module rather than a transducer. The electronic device141 can be, for example, a monitor or display of a computer, such as alaptop computer or a desktop computer, or a handheld electronic devicesuch as a tablet, phone or other electronic device configured to receiveand display the output of the force sensor device 148.

The positioning device 142 can include other various components that canbe for example coupled to or incorporated within the handle assembly 144or another component of the positioning device 142. The docking member146 can be used to releasably couple the epicardial pad 100 to thepositioning device 142 and can be actuated by one or more components ofthe positioning device 142. The tether securing device 147 can include,for example, a vice mechanism used to lock the tether 128 at a desiredposition. In some embodiments, the tether securing device 147 caninclude a pinning device that can pierce the tether 128 to secure thetether 128 in the desired position. More detailed descriptions ofvarious components of embodiments of a positioning device 142 aredescribed below.

FIGS. 4-12 illustrate an epicardial anchor device according to anembodiment. An epicardial anchor device 200 includes a tether attachmentmember 224, a pad assembly 220, a tube member 255 and a tube covermember 256. The tether attachment member 224 includes a base member 240,a hub 250, a retaining ring 252, a locking pin assembly 226, and a pinmember 253. The locking pin assembly 226 includes a driver portion 246and a piercing portion 249. The base member 940 defines acircumferential pad channel 242, a retaining channel 251 and a lockingpin channel 234. The pad channel 242 can be used to couple the padassembly 220 to the tether attachment member 224. The retaining channel251 can receive an outer edge of the retaining ring 252, which is usedto retain the hub 250 to the base member 240. The base member 240 alsodefines cutouts or detents 243, as shown for example, in FIGS. 5, 7 and12.

The tube member 255 is coupled to the base member 240 and the basemember 240, the hub 250 and the tube member 255 collectively define atether passageway 235 through which a tether (not shown) can bereceived. The cover member 256 can be formed with a fabric material,such as for example, Dacron®. The tether channel 235 intersects thelocking pin channel 234 and is in fluid communication therewith.

The pad assembly 220 includes a top pad portion 258, a bottom padportion 259 and a filler member 257 disposed therebetween. The top padportion 258 and the bottom pad portion 259 can each be formed with, forexample, a flexible fabric material. The top pad portion 258 and thebottom pad portion 259 can each define a central opening through whichthe tube member 255 can pass through. A portion of the top pad portion258 is received within the channel 242 of the base member 240 as shown,for example, in FIGS. 7-9.

An outer perimeter portion of the hub 250 is received within theretaining channel 251 such that the hub 250 can rotate relative to thebase member 240 to actuate the locking pin assembly 226 as described inmore detail below. As shown, for example, in FIGS. 10 and 11, the hub250 includes arms 261 with protrusions 262. The protrusions 262 can bereceived within cutouts 243 of the base member 240 and act as a stop orlimit to the rotation of the hub 250. The hub 250 defines slots 263 thatenable the arms 261 to flex and allow the protrusions 262 to be moved inand out of the cutouts 243. As shown, for example, in FIGS. 9 and 10 thehub 950 defines a curved channel 250 on a bottom portion of the hub 950.The curved channel 250 is asymmetrical (or spiral) and receives thedriver portion 246 of the locking pin assembly 226. As the hub 250 isrotated relative to the base member 240, the hub 250 acts as a cam tomove the locking pin assembly 226 linearly within the locking pinchannel 234. The locking pin assembly 226 can be moved from a firstposition in which the piercing portion 249 is disposed outside of thetether passageway 235 as shown in FIGS. 7 and 8, and a second positionin which the piercing portion 249 extends through the tether passageway235 as shown in FIG. 9. The pin member 253 (see, e.g., FIG. 8) can beformed with a metal material that is more radio-opaque than the othercomponents of the anchor device and thus visible to the user (e.g.physician) using conventional imaging modalities to enable the user toconfirm that the locking pin assembly 226 has been fully moved to thesecond position.

In use, when the locking pin assembly 226 is in the first position, atether (not shown) coupled to, for example, a prosthetic mitral valveand extending through a puncture site in the ventricular wall of a heartcan be inserted through the tether passageway 235. The hub 250 can thenbe rotated 180 degrees to move the locking pin assembly 226 linearlywithin the locking pin channel 234 such that the piercing portion 249extends through the tether passageway 235 and engages or pierces thetether, securing the tether to the tether attachment member 224. Forexample, the hub 250 also defines a driver receiving opening 210configured to receive a mating portion of a positioning device(described below, e.g., with reference to positioning devices 242, 342and 442). The positioning device can be used to rotate the hub andactuate the locking pin assembly 226. When the locking pin is in thefirst position, the protrusions 262 of the hub 250 are each disposedwithin one of the cutouts 243 of the base member 240 (i.e., a firstprotrusion is in a first cutout, and a second protrusion is in a secondcutout). The hub 250 can then be rotated 180 degrees such that theprotrusions 262 are moved out of the cutouts 243 of the base member 240and at the end of the 180 degrees the protrusions 262 are moved into theother of the cutouts 243 of the base member 240 (i.e., the firstprotrusion is now in the second cutout, the second protrusion is now inthe first cutout).

The base member 240 can also include cutout sections 266 and define sideopenings 267 (see, e.g., FIGS. 4 and 5) that can be used to couple apositioning device to the epicardial anchor device 200. For example,FIGS. 13-17B illustrate a positioning device 242 that can be used todeploy and position an epicardial anchor device such as anchor device200.

As shown in FIG. 13, in this embodiment, the positioning device 242includes an elongate member 245, a docking member 246 coupled to adistal end of the elongate member 245, a handle assembly 244 and atether securing member 247. The handle assembly 244 includes a housing254, a transparent tube segment 223 with indications disposed thereon, atension member 229, a thumb dial 227, a release button 233 and a safetylever 231.

The handle assembly 245 is coupled to the tether securing device 247with a rod member 264 (see, e.g., FIG. 15). The handle assembly 245 isalso coupled to the elongate member 245, which is coupled to the dockingmember 246. The docking member 246 includes coupling arms 236 withcoupling pins 238 extending inwardly from the coupling arms 236. Thecoupling pins 238 are configured to be received within the side openings267 of the anchor device 200 described above, and the coupling arms 236can engage the cutout sections 266 of the anchor device 200. Thecoupling arms 236 have hinged joints which are coupled to a disc member239. The disc member 239 can be coupled to or incorporated with ormonolithically formed with the elongate member 245. A spring 216disposed between the disc member 239 and the arms 236 biases thecoupling arms 236 in a closed position as shown, for example, in FIGS.13, 15 and 16. The coupling arms 236 can be moved to an open position(not shown) to allow for the anchor device 200 to be received betweenthe coupling arms 236 to couple and release the anchor device 200 to andfrom the positioning device 242. Actuation of the docking member 236 isdescribed in more detail below. An inner driver member 217 is movablydisposed within a lumen defined by the elongate member 245 and extendsthrough the docking member 246. The inner driver member 217 includes ashaped distal tip 237 that is configured to be matingly received withinthe driver receiving opening 210 of the anchor device 200. The innerdriver member 217 is operatively coupled to the thumb dial 227 of thepositioning device 242 and can be used to actuate the locking pinassembly 226 of the anchor device 200 to secure a tether to the anchordevice 200, as described below.

The safety lever 231 is hingedly coupled to the housing 254 and can bemoved from a first position as shown, for example, in FIG. 13, in whichthe safety lever 231 prevents the release button 233 from moving and asecond position (not shown) in which the safety lever 231 is pivoted ormoved in a direction upward away from the elongate member 245 such thatthe release button 223 can be moved as desired as described in moredetail below.

In use, a tether (not shown) extending from a prosthetic mitral valveand outside of the heart can be inserted through the epicardial anchordevice 200 and threaded through a lumen of the inner driver member 217,through the handle assembly 244, and out through the tether securingdevice 247.

To releasably couple and uncouple the anchor device 200 to and from thepositioning device 242, the safety lever 231 is moved to its secondposition in which the release button 233 is free to move. The releasebutton 233 is fixedly coupled to the elongate member 245 such that asthe release button is moved distally, the elongate member 245 movesdistally, and in turn the disc member 239 moves distally compressing thespring 216 and actuating the hinged coupling arms 236 of the dockingmember 246 to open wide enough such that the anchor device 200 can beplace therebetween. The distal tip 237 of the driver member 217 isreceived within the opening 210 of the anchor device 200. The releasebutton 233 can then be moved proximally to allow the coupling arms 236to move back to their biased closed position (e.g., closer together) andbe inserted into the side openings 267 of the anchor device 200. Thesafety lever 231 can then be moved back to its first position, as shownin FIG. 13.

With the anchor device 200 coupled to the positioning device 242, theanchor device 200 can be positioned at a desired location on the outersurface of the ventricular wall of the heart, such as for example, atthe apex. The tether extending through the positioning device 242 andout the proximal end of the positioning device 242 can be pulledproximally to a desired tension. When the tether is drawn/pulled to thedesired tension, e.g., such that the deployed prosthetic valve seatsfirmly in the native annulus and any regurgitation seen on fluoroscopyor echocardiography is no longer present, the practitioner can fine tunethe tensioning by visually observing the tether within the transparenttube segment 223 and compare the longitudinal distance travelled againstan implant position scale. When the tether is suitably located, thelocking pin assembly 226 of the anchor device 200 can be actuated by thepositioning device 242 to lock the tether in place on the epicardialanchor device 200. For example, the thumb dial 227, which is operativelycoupled to the driver member 217, can be rotated to actuate the lockingpin assembly 226 of the anchor device 200 to pierce the tether andsecure the tether to the anchor device 200.

Prior to pinning the tether to the anchor device 200, it may bedesirable to make small adjustments or fine tuning to the position ofthe anchor device 200 and/or to the tension of the tether. To make suchadjustments or fine tuning, the tether securing device 247 can be usedto secure the tether at a fixed position on the positioning device 242,such that the anchor device 200 can be pushed distally snug to the outerwall of the heart. For example, in this embodiment, the tether securingdevice 247 includes a collet 212 (see, e.g., FIGS. 15 and 17A) thatprovides a friction fit against the tether when the tether securingdevice 247 is rotated. If an adjustment to the tension of the tetherand/or to the position of the anchor device 200 is desired, with thetether securing device 247 holding the tether in a fixed position, thetension member 229 can be actuated to allow the handle assembly 244,elongate member 245 and docking member 246 to be moved distally relativeto the rod member 264 to which the tether securing device 247 iscoupled. For example, as shown in FIGS. 17A and 17B, grooved teeth 265of the rod member 264 allow the handle assembly 244 to be incrementallymoved distally. Alternatively, the push buttons 219 on the tensionmember 229 can be depressed which will release the grooved teeth 265 andallow the handle assembly 244 to be slid freely relative to the rodmember 264.

When the anchor device and tether have been secured in a desiredposition and at a desired tension, the positioning device 242 can beactuated to pin the tether to the anchor device 200 as described above,and then the epicardial anchor device 200 can be released from thepositioning device 242. The portion of the tether extending from theanchor device 200 can be cut to a desired length and/or tied off.

FIGS. 18-21 illustrate another embodiment of a positioning device thatcan be used to position an epicardial anchor device such as anchordevice 200. As with the previous embodiment, the positioning device 342includes an elongate member 345, a docking member 346 coupled to adistal end of the elongate member 345, and a handle assembly 344 coupledto the elongate member 345. The handle assembly 344 includes a housing354, a transparent tube member 323 with indications disposed thereon, atension member 329, a thumb dial 327, a release button 333 and a safetylever 331. Each of these components can be the same as or similar to thecorresponding components of positioning device 242 and are therefore notdiscussed in detail with respect to this embodiment.

In this embodiment, the positioning device 342 also includes a forcesensor device 348 coupled at a proximal end of the positioning device342. The force sensor device 348 can be coupled to the housing 344 via arod member 364 similar to the rod member 264. The force sensor device348 includes a sensor housing 369 defining an interior region thatreceives a load cell 368. In some embodiments, the load cell caninclude, for example a piezoelectric sensor. In some embodiments theload cell 368 can include miniature strain gauges. The load cell 368 canbe electrically coupled to a transducer (not shown) or a dataacquisition module (not shown) via a cable 311, which in turn cancommunicate with an electronic device (not shown) configured to displaythe output of the force sensor device 348 as described above withrespect to FIG. 3. The electronic device can be, for example, a monitoror display of a computer, such as a laptop computer or a desktopcomputer, or a handheld electronic device such as a tablet, phone orother electronic device configured to receive and display the results ofthe force sensor device 348.

The positioning device 342 can also include a tether securing device 347coupled proximally to force sensor device 348. The tether securingdevice 347 includes a collet (not shown) that provides a friction fitagainst a tether when the tether securing device 347 is rotated asdescribed for the previous embodiment. As shown in the schematicillustration of FIG. 21, the rod member 364 can extend through the forcesensor device 348 and the tether securing device 347 can be coupledthereto.

In use, as with the previous embodiment, a tether (not shown) extendingfrom a prosthetic mitral valve and outside of the heart can be insertedthrough an epicardial anchor device, threaded through the elongatemember 345, through the handle assembly 344, and out through the tethersecuring device 347. The anchor device can be releasably coupled to thepositioning device 342 in the same manner as described above forpositioning device 242 and the locking pin assembly of the anchor devicecan be actuated to pin the tether to the anchor device as describedabove.

The anchor device 200 can be positioned at a desired location on theouter surface of the ventricular wall of the heart, such as for example,at the apex. The tether extending through the positioning device 342 canbe pulled proximally to a desired tension. In this embodiment, thetension on the tether can be measured and displayed for thepractitioner. For example, tether securing device 347 exerts acompressive force on the load cell 368 as the tether is being pulledthrough. The compressive force displaces the load cell, which causes adeflection of the load cell which is detected by the sensor(s) withinthe load cell 368. The deflection data is sent to the data acquisitionmodule which in turn provides pressure data to be viewed on anelectronic display. When the desired tension on the tether is achieved,the tether securing device 347 can be used to secure the tether at afixed position relative to the positioning device 342 as describedabove.

If an adjustment to the tension of the tether and/or to the position ofthe anchor device on the tether is desired, with the tether securingdevice 347 holding the tether in a fixed position, and while holding thetether securing device 347, the tension member 329 can be actuated toallow the handle assembly 344, elongate member 345 and docking member346 to be moved distally relative to the rod member 364 and tethersecuring device 347. For example, as previously described, the tensionmember 329 can be used to incrementally move the handle assembly 344distally or push buttons 319 on the tension member 329 can be depressedwhich will release grooved teeth 365 on the rod member 364 and allow thehandle assembly 344 to be slid freely relative to the rod member 364.

When the anchor device and tether have been secured in a desiredposition and at a desired tension, the positioning device 442 can beactuated to release the epicardial anchor device. The portion of thetether extending from the anchor device can be cut to a desired lengthand/or tied off.

FIGS. 22-28 illustrate a positioning device 442 according to anotherembodiment. The positioning device 442 can be configured the same as orsimilar to and provide the same or similar functions as the abovedescribed embodiments. The positioning device 442 includes a dockingmember 446 coupled to a distal end of an elongate member 445, a handleassembly 444 and a force sensor device 448. The positioning device 442can also include a tether securing device (not shown) that can be thesame as or similar to the tether securing devices described above. Thehandle assembly 444 includes a housing 454 having a transparent segment423 with indications disposed thereon, a tension member 429, a switch427, a release knob 433 and a safety lever 431.

The handle assembly 445 is coupled to the elongate member 445, which iscoupled to the docking member 446. The docking member 446 includescoupling arms 436 with coupling pins 438 extending inwardly from thecoupling arms 436. As with the previous embodiments, the coupling pins438 are configured to be received within the side openings of an anchordevice such as anchor device 200 described above. The coupling arms 436can also engage the cutout sections of the anchor device as describedabove. The coupling arms 436 have hinged joints which are coupled to adisc member 439 which is coupled to or incorporated or monolithicallyformed with the elongate member 445. A spring 416 is disposed betweenthe disc member 439 and the arms 436 and biases the arms 436 in a closedposition as shown, for example, in FIGS. 13, 15 and 16. The couplingarms 436 can be moved to an open position (not shown) to allow for theanchor device to be received between the coupling arms 436 to couple andrelease the anchor device to and from the positioning device 442.Actuation of the docking member 436 is described in more detail below.An inner driver member 417 is movably disposed within a lumen defined bythe elongate member 445 and extends through the docking member 446. Theinner driver member 417 includes a shaped distal tip 437 that isconfigured to be matingly received within a driver receiving opening ofthe anchor device as described above. The inner driver member 417 isoperatively coupled to the switch 427 of the positioning device 442 andcan be used to actuate the locking pin assembly of the anchor device tosecure a tether to the anchor device, as described above for previousembodiments.

The safety lever 431 can be moved from a first position as shown inFIGS. 22, 24 and 25 in which the safety lever 431 prevents the releasebutton 433 from moving and a second position (not shown) in which thesafety lever 433 is moved in a direction downward away from the elongatemember 445 such that the release button 433 can be moved as desired asdescribed in more detail below.

As shown in FIGS. 26-30, in this embodiment, the force sensor device 448includes a sensor housing 470, a fluid chamber 472 and a load washer474. The fluid chamber 472 defines an interior region that can contain afluid and that is in fluid communication with a conduit 476. The fluidchamber 472 is received within the sensor housing 470 and the conduit476 extends out of the sensor housing 470 through an opening 475 definedby the sensor housing 470. The load washer 474 is disposed over thefluid chamber 472 and is coupled to the sensor housing 470 with pins 471such that the load washer 474 can move within slots 477 defined by thesensor housing 470. This allows for the fluid chamber 472 to reduce andexpand in size within the interior region defined collectively by thesensor housing 470 and the load washer 474. A fluid port connector 473is coupled to the conduit 476. The fluid port connector 473 can be forexample, a Luer connector. The fluid port connector 473 can be coupledto a pressure transducer (not shown) which in turn can be coupled to adevice that can be used to display pressure readings received from thepressure transducer. In some embodiments, the pressure transducer can beincorporated within the force sensor device 448, or coupled directly toor proximate to the force sensor device 448. During use, force isexerted on the load washer 474 which in turn exerts a compressive forceon the fluid chamber 472 causing the pressure of the fluid in theinterior region of the fluid chamber 472 to be increased. This increasedpressure can be communicated through the fluid from the fluid chamber472 to and through the conduit 476. The force sensor device 448 can beused to measure the load on a tether extending through the positioningdevice 442. For example, the positioning device 442 can include a tethersecuring member (not shown) that can be configured the same as orsimilar to the tether securing device 247 described above. In a similarmanner as shown for force sensor device 448 (see, e.g., FIG. 21), therod member 464 can extend through the force sensor device 448 and thetether securing device can be coupled to the rod member 465 and disposedon a proximal side of the force sensor device 448 in contact with theload washer 474. As the tether is pulled through to a desired tension,the tether securing device exerts a force on the load washer 474.

In use, a tether (not shown) extending from a prosthetic mitral valveand outside of the heart can be inserted through an epicardial anchordevice 400 (see, FIG. 22) and threaded through a lumen of the innerdriver member 417, through the handle assembly 444, and out through thetether securing device (not shown). For purposes of the followingdescription, the epicardial anchor device 400 can be the same as theepicardial anchor device 200 described above.

To releasably couple and uncouple the anchor device 400 to and from thepositioning device 442, the safety lever 431 is moved to its secondposition in which the release button 433 is free to move. The releasebutton 433 is fixedly coupled to the elongate member 445 such that asthe release button 433 is moved distally, the elongate member 445 movesdistally, and in turn the disc member 439 moves distally compressing thespring 416 and actuating the hinged coupling arms 436 of the dockingmember 446 to open wide enough such that the anchor device 400 can beplace therebetween. The distal tip 437 of the driver member 417 isreceived within the mating opening of the anchor device 400 as describedabove for anchor device 200. The release knob 433 can then be movedproximally to allow the coupling arms 436 to move back to their biasedclosed position (e.g., closer together) and be inserted into the sideopenings of the anchor device 400. The safety lever 431 can then bemoved back to its first position, as shown in FIGS. 24 and 25.

With the anchor device 400 coupled to the positioning device 442, theanchor device 400 can be positioned at a desired location on the outersurface of the ventricular wall of the heart, such as for example, atthe apex. The tether extending through the positioning device 442 andout the proximal end of the positioning device 442 can be pulledproximally to a desired tension. When the tether is drawn/pulled to thedesired tension, e.g., such that the deployed prosthetic valve seatsfirmly in the native annulus and any regurgitation seen on fluoroscopyor echocardiography is no longer present, the practitioner can fine tunethe tensioning by visually observing the tether within the transparentsegment 423 and comparing the longitudinal distance travelled against animplant position scale. Further, as shown in FIG. 29, the transparentsegment 423 includes markings or indications 415. In this example, themarkings 415 include indications between 5 and 15 centimeters. Differentindications and/or increments can be used as appropriate. A distalportion of the rod member 464 can be viewed through the transparentsegment 423 and includes an indicator 418 at a distal end of the rodmember 464. The indicator 418 can be a marking on the rod member 464 ora separate component coupled to the rod member 464. In some embodiments,the indicator 418 can be color coded. The indicator 418 shows thelocation of the rod member 464 as the rod member 464 is moved in aproximal and distal direction and corresponds to a distance between thebottom surface of the epicardial pad device 400 that contacts the heartand the annulus of the heart valve. For example, the markings 415 can beused to identify the location of the indicator 418 on the distal end ofthe rod member 464. The distance between the bottom surface of theepicardial pad device 400 that contacts the heart and annulus of theheart can be determined based on a known length of the tether. Forexample, a proximal end portion of the tether extending out of thepositioning device 442 can have a marker 414 (see FIG. 39 illustrating atether 428 with a marker 414 coupled thereto). The marker 414 can be forexample, a stainless steel hypotube or band crimped or swaged onto thetether. The marker 414 on the tether can indicate a preset distance fromwhere the prosthetic mitral valve is seated in the annulus. For example,the marker 414 can be a set distance of 40 mm from where the tether isattached at the cuff of the prosthetic mitral valve. From this, when thetether is extended through the positioning device 442, depending on thetension applied to the tether, the location of the indicator 418 on therod member 464 can represent the distance between the epicardial paddevice 400 that contacts the heart and annulus of the heart.

When the tether is suitably located, the locking pin assembly of theanchor device 400 can be actuated by the positioning device 442 to lockthe tether in place on the epicardial anchor device 400. For example,the switch 427, which is operatively coupled to the driver member 417,can be actuated to rotate the driver member 417 and actuate the lockingpin assembly of the anchor device 400 to pierce the tether and securethe tether to the anchor device 400. In some embodiments, the switch 427can be moved or flipped 180 degrees. For example, the driver member 417can be moved 180 degrees to rotate the driver inward to actuate the pinlocking assembly of the anchor device 400 and secure the tether, andthen back 180 degrees to move the driver member 417 in the oppositedirection to release the tether.

Prior to pinning the tether to the anchor device 400, it may bedesirable to make small adjustments or fine tuning to the position ofthe anchor device 400 and/or to the tension of the tether. To make suchadjustments or fine tuning, the tether securing device (not shown) canbe used to secure the tether at a fixed position on the positioningdevice 442, such that the anchor device 400 can be pushed distally snugto the outer wall of the heart in a similar manner as described abovewith respect to positioning device 242. For example, in this embodiment,the rod member 464 can move proximally and distally relative to thehandle assembly 444. While holding the tether securing device, thetension member 429 can be actuated (e.g., rotated) such that the rodmember 464 rotates proximally with the tether securing device (notshown). For example, the tension member 429 can be coupled to the rodmember 464 such that rotating of the tension member 429 causes the rodmember to move proximally or distally depending on the direction ofrotation of the tension member 429. This can provide the ability to makefine adjustments to the tension on the tether. In addition, the releasebutton(s) 419 on the tension member 429 can be pressed to allow thetension member 429 to disengage from the teeth 465 of the rod member 464and be freely slid relative to the rod member 464. In this manner, thetension member 429 can be slid distally, which in turn moves the handleassembly 444, elongate member 445 and docking member 446 distallyrelative to the rod member 464 and tether securing device.

As with the previous embodiment, the tension on the tether can bemeasured and displayed for the practitioner via the force sensor device448. For example, as described above, the tether securing device (notshown) can exert a compressive force on the load washer 474 as thetether is being pulled through.

When the anchor device and tether have been secured in a desiredposition and at a desired tension, the positioning device 442 can beactuated to pin the tether to the anchor device 400 as described above,and then the epicardial anchor device 400 can be released from thepositioning device 442. The portion of the tether extending from theanchor device 400 can be cut to a desired length and/or tied off.

FIG. 31 illustrates a tension limiting device (also referred to as“tensioner”) that can be included in the positioning devices describedherein. The tensioner 480 can be incorporated within, for example, thetension member 429′ and can be used to limit the amount of load (e.g.tension T) that can be set during prosthetic valve implantation. Thetensioner 477 includes ratchet members 478 and 479 that skip over eachother when maximum tension on the lead screw is achieved. A spring 483is coupled to the rod member 464 and applies tension on the ratchetmembers 478 and 479. The ratchet member 479 can be coupled to thehousing of the tension member 429 and can move axially along the rodmember 464. The ratchet member 478 includes inner teeth that engage theteeth 465 of the rod member 464 such that the ratchet member 478 can bemoved along the rod member 464 as the tension member 429 is rotated. Forexample, as the tension member 429 is rotated to adjust the tension onthe tether, the ratchet member 479 will move with the tension member 429and the ratchet member 478 will slide relative to the ratchet member 479until the tension on the tether exceeds a set value, at which point thetensioner 480 will act like a slip clutch, preventing furthertensioning. The tension limit can be a preset value of the device or canbe set according to the particular procedure and/or patient.

FIGS. 36 and 37 illustrate an alternative embodiment of a force sensordevice 648 that can be included on a positioning device describedherein. The force sensor device 648 is similar to the force sensordevice 448 and can function in the same or similar manner as the forcesensor device 448. The force sensor device 648 includes a sensor housing670, a fluid chamber 672 and a load washer 674. The fluid chamber 672defines an interior region that can contain a fluid and that is in fluidcommunication with a conduit 676. The fluid chamber 672 is receivedwithin the sensor housing 670 and the conduit 676 extends out of thesensor housing 670 through an opening 675 defined by the sensor housing670. The load washer 674 is disposed over the fluid chamber 672 and iscoupled to the sensor housing 670 with a retainer 686 such that the loadwasher 674 can move or float relative to the sensor housing 670. Forexample, the load washer includes a perimeter flange (not shown) onwhich the retainer 686 rests on top of the sensor housing 670. Thisallows for the fluid chamber 672 to reduce and expand in size within theinterior region defined collectively by the sensor housing 670 and theload washer 674. A spring 688 and adjuster screw 684 are disposed withinan opening 690 (FIG. 38) defined in the sensor housing 670 and can beused to tune the pressure reading at a fixed load. The opening 690 isalso used to couple the force sensor device 648 to a rod member (e.g.,464) of a positioning device (e.g., 642).

In this embodiment, a tether (not shown) extending through thepositioning device to which the force sensor device 648 is coupled,extends through the rod member of the positioning device, through theadjuster screw 684 and spring 688, through load washer 674 and out aproximal opening 691 defined in the load washer 674 at a proximal end ofthe force sensor device 648. In this embodiment, a pinning mechanismincorporated into the force sensor device 648 can be used to pierce thetether and secure the tether to the force sensor device 648. The pinningmechanism includes a pin holder 685 coupled to a pin 687. The pin holder685 can be manually moved inward to actuate or move the pin 687 inwardlyinto the opening 691 (see., e.g., FIG. 38) to pierce a tether extendingtherethrough.

A fluid port connector 673 is coupled to the conduit 676. The fluid portconnector 673 can be for example, a Luer connector. The fluid portconnector 673 can be coupled to a pressure transducer 649 via a conduit(not shown) which is disposed within a holder portion 689 defined in thesensor housing 670. The pressure transducer 649 being incorporatedwithin the force sensor device 648 can compensate for tool heightchanges during a procedure that could change the pressure reading. Thepressure transducer 649 can in turn be coupled to a device that can beused to display pressure readings received from the pressure transducer649.

In this embodiment, during use, when the tether is pierced by the pin687, the load is transferred to the load washer 674, which in turnexerts a compressive force on the fluid chamber 672 causing the pressureof the fluid in the interior region of the fluid chamber 672 to beincreased. This increased pressure can be communicated through the fluidfrom the fluid chamber 672 to and through the conduit 676 and to thepressure transducer 649 via a conduit (not shown) connecting the conduit676 to the pressure transducer 649 via the connector 673. The forcesensor device 648 can be used to measure the load on a tether extendingthrough the positioning device to which the force sensor device 648 iscoupled.

For each of the embodiments of a positioning device described herein(242, 342, 442), in some cases, after deployment, the tether may be lefthaving excess length, i.e. not trimmed, in order to facilitate latercapture if necessary. If it is determined that the length of the tetheris not suitable for some reason, e.g., regurgitation is seenpost-procedure and the tether is too slack or the tension is too highand the apical tissue is invaginating or changing the shape of the heartin an unwanted manner, the positioning device can be used to capture theexcess untrimmed tail of the tether, thread the tether through thepositioning device, re-engage the epicardial anchor device, unlockingthe pin assembly of anchor device and allowing for the tether lengthadjustment. The tether may then be adjusted length-wise, either shorteror longer, and the tether is then re-tested for tensioning force,re-pinned and locked into place with the epicardial anchor device.

In some cases, tether tightening or shortening may be, for example, inthe range from about 1 mm-10 mm, or about 1 mm-8 mm, or about 1 mm-5 mm,or about 2 mm-8 mm, or about 2 mm-5 mm in length, and all rangesinclusive. Tether loosening or lengthening is contemplated as rangingfrom about 1 mm-10 mm, or about 1 mm-8 mm, or about 1 mm-5 mm, or about2 mm-8 mm, or about 2 mm-5 mm in length and all ranges inclusive.

It is contemplated that the time range for which post-deploymentadjustments to the tether length or position can be, for example, fromabout 0.5 hours-48 hours, or from about 24 hours-72 hours, or from about1 day-7 days, or from about 1 day-15 days, or from about 1 day-30 days,post-implantation.

In an alternative embodiment of a positioning device, a force sensordevice can be included that includes a mechanical indicator. Forexample, a spring device may be connected to a mechanical tension meterto show load range. A load of 1-2 lbs. or 1-4 lbs. are examples of atypical target load.

Although not shown, an alternative to the vice type of tether securingdevice described herein (e.g., 247, 347), a pinning device that can beused. For example, such a device can include a portion through which thetether can be threaded, and a pin member can be operatively coupledthereto and actuated to pierce through the tether to hold the tether inposition. Such a device can be incorporated into a positioning deviceand be operatively coupled to an actuation mechanism. In someembodiments, such a pinning mechanism can be manually actuated.

FIGS. 32-35 illustrate an alternate embodiment of a tether release toolthat can be used for capturing a tether, and engaging/re-engaging anepicardial pad after it has been deployed. As shown, for example, inFIGS. 32 and 33, the tether release tool 580 includes a handle 581coupled to an elongate positioning rod 582. The positioning rod 582includes a shaped anchor engagement tip 583 and defines a tethercapture/recapture access port 584. As shown in FIG. 33, the anchorengagement tip 583 is shaped to be received in a corresponding matingopening 510 of an epicardial anchor device 500 (see, FIGS. 34 and 35),which can be configured the same and function the same as the epicardialanchor device 200 described above. The engagement tip 583 defines anopening 585 that is in fluid communication with the access port 584.

After the epicardial anchor device 500 has been deployed and the tether528 has been pinned to the anchor device 500, the tether release tool580 can be used to release the tether to allow the practitioner to makeadjustments to the tension on the tether 528 and/or to the position ofthe anchor device 500. As shown in FIGS. 34 and 35, a portion of thetether 528 extending from the anchor device 528 is inserted through thedistal opening 585 and out through the access port 584. The engagementtip 583 can be inserted into the mating opening 510 of the anchor device500. The tether release tool 580 can be rotated to unlock the lockingassembly of the anchor device 500 to release the tether 528 from theanchor device 500. With the tether 528 released, the tension on thetether can be adjusted and/or the position of the anchor device 500 onthe heart can be adjusted and then the tether release tool 580 can beused to re-pin the tether 528 to the anchor device. For example, theengagement tip 583 can be inserted into the mating opening 510 of theanchor device 500 and rotated the opposite direction to re-actuate thelocking pin assembly of the anchor device 500 and pin the tether 528 tothe anchor device 500.

In some embodiments, there is a tether-bundle that attaches to theextended points (two or three or four) of the stent and which convergeto a central nexus point to which the adjustable tether is attached andleads to the apical tissue anchor location within the heart. In someembodiments, the tether extends downward through the left ventricle,exiting the left ventricle at the apex of the heart to be fastened onthe epicardial surface outside of the heart. Similar anchoring iscontemplated herein as it regards the tricuspid, or other valvestructure requiring a prosthetic.

As described herein, during deployment of a prosthetic heart valve, theoperator is able to adjust or customize the tethers to the correctlength for a particular patient's anatomy. The tethers also allow theoperator to tighten the cuff onto the tissue around the valvular annulusby pulling the tethers, which creates a leak-free seal. In someembodiments, the tethers are optionally anchored to other tissuelocations depending on the particular application of the prostheticheart valve. In the case of a mitral valve, or the tricuspid valve,there are optionally one or more tethers anchored to one or bothpapillary muscles, septum, and/or ventricular wall.

The tethers, in conjunction with the cuff of the valve, provide for acompliant valve which has heretofore not been available. The tethers canbe made from surgical-grade materials such as biocompatible polymersuture material. Examples of such material include 2-0 exPFTE(polytetrafluoroethylene) or 2-0 polypropylene. In one embodiment, thetethers are inelastic. It is also contemplated that one or more of thetethers may optionally be elastic to provide an even further degree ofcompliance of the valve during the cardiac cycle. In some embodimentsthe tether(s) may be bioresorbable/bioabsorbable and thereby providetemporary fixation until other types of fixation take hold such abiological fibrous adhesion between the tissues and prosthesis and/orradial compression from a reduction in the degree of heart chamberdilation.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components, and/or features of thedifferent embodiments described. For example, although not necessarilydescribed for each embodiment, the various positioning devices (242,342, 442) can include any features and or functions described herein forthe various embodiments.

What is claimed is:
 1. An apparatus, comprising: a handle assemblycoupled to an elongate member; a docking member coupled to a distal endof the elongate member, the docking member configured to be releasablycoupled to an epicardial anchor device configured to secure a tetherextending from a prosthetic heart valve implanted within a heart at alocation on an exterior of a ventricular wall of the heart; and a forcesensor device coupled to the handle assembly and including a pinningmechanism, the force sensor device configured to measure a force exertedon the force sensor device, the force associated with a tension of thetether extending through the elongate member and handle assembly, thepinning mechanism configured to secure the tether to the force sensordevice.
 2. The apparatus of claim 1, wherein the docking member furtherincludes a plurality of arms configured to be releasably coupled to theepicardial anchor device.
 3. The apparatus of claim 1, furthercomprising: a rod member coupled to the handle assembly; and a tensionmember coupled to the rod member, the tension member configured to bemoved distally relative to the rod member to adjust the tension on thetether extending through the elongate member and handle assembly.
 4. Theapparatus of claim 1, further comprising: a rod member coupled to thehandle assembly; and a tension member coupled to the rod member, the rodmember configured to be moved proximally when the tension member isrotated to adjust the tension on the tether extending through theelongate member and handle assembly.
 5. The apparatus of claim 1,wherein the pinning mechanism includes a pin and a pin holder forreceiving at least a portion of the pin, the pin configured to pierceand secure the tether to the force sensor device.
 6. The apparatus ofclaim 5, wherein the force sensor device includes a load washer, a firstportion of the pin holder being received within the load washer and asecond portion of the pin holder extending from the load washer.
 7. Theapparatus of claim 6, wherein the load washer defines an openingconfigured to receive the tether, wherein, in a first position, the pinholder is at a first distance from the opening of the load washer and,in a second position, the pin holder is at a second distance from theopening of the load washer, the first distance being greater than thesecond distance.
 8. The apparatus of claim 7, wherein, in the firstposition, a second portion of the pin is outside of the opening of theload washer and, in the second position, the second portion of the pinis received within the opening of the load washer.
 9. The apparatus ofclaim 8, wherein the force sensor device includes a housing coupled tothe elongate member, the housing defining an opening in communicationwith a lumen of the elongate member.
 10. The apparatus of claim 9,wherein the housing receives a screw and a spring, the screw and springconfigured to tune a pressure reading at a fixed load.
 11. A methodcomprising: inserting a tether through an epicardial anchor device, thetether extending from a prosthetic heart valve implanted within a heart,the tether extending outside of the heart, coupling the epicardialanchor device to a docking member disposed at a first end of apositioning device; inserting the tether through the positioning device;actuating a pinning mechanism disposed at a second end of thepositioning device to secure the tether to the positioning device; whilethe tether is secured to the positioning device, tensioning the tetheruntil a desired tension on the tether is achieved; and releasing theepicardial anchor device from the docking member.
 12. The method ofclaim 11, further comprising measuring a force exerted on the forcesensor device, the force associated with a tension of the tetherextending through the positioning device.
 13. The method of claim 12,wherein the force sensor device includes a sensor housing, a fluidchamber disposed within the sensor housing and a load washer coupled tothe sensor housing such that the fluid chamber is disposed between thesensor housing and the load washer, and measuring the force includesmeasuring a displacement of a volume of fluid disposed within the fluidchamber when a force is exerted on the load washer.
 14. The method ofclaim 11, wherein the pinning mechanism includes a pin and a pin holderfor receiving at least a portion of the pin, and wherein a first portionof the pin holder is received within the force sensor device and asecond portion of the pin holder extends from the force sensor device,and actuating the pinning mechanism includes moving the second portionof the pin holder.
 15. The method of claim 14, wherein the force sensordevice defines an opening, and moving the second portion of the pinholder includes moving the pin holder towards the opening.
 16. Themethod of claim 15, further comprising receiving the tether within theopening of the force sensor device and wherein moving the second portionof the pin holder includes securing the tether to the force sensordevice.
 17. The method of claim 16, wherein moving the second portion ofthe pin holder includes piercing, with the pin, the tether received inthe opening of the force sensor device.
 18. The method of claim 15,further comprising moving the second portion of the pin holder away fromthe opening of the force sensor device to release the tether.
 19. Asystem comprising: an epicardial anchor device; a flexible member; apositioning device comprising: a handle assembly coupled to an elongatemember; a docking member coupled to a distal end of the elongate member,the docking member releasably coupled to the epicardial anchor deviceand configured to secure the flexible member extending from a prostheticheart valve implanted within a heart at a location on an exterior of aventricular wall of the heart; and a force sensor device coupled to thehandle assembly and including a pinning mechanism, the force sensordevice configured to measure a force exerted on the force sensor device,the force associated with a tension of the flexible member extendingthrough the elongate member and handle assembly, the pinning mechanismconfigured to secure the flexible member to the force sensor device. 20.The apparatus of claim 19, wherein the pinning mechanism includes a pinand a pin holder for receiving at least a portion of the pin, the pinconfigured to pierce and secure the tether to the force sensor device.